Interventional Cardiovascular Device Development: Considerations in Clinical Trial Implementation

As cardiac technology continues to advance, medical device developers are working rapidly to bring new implantable cardiovascular devices to market. When preparing for a clinical trial, there are multiple factors to consider in the scientific design and implementation of your study. Careful consideration of trial design, site/patient selection, data collection and endpoint evaluation are vital to success. In this webinar, we will share best practices to help guide cardiovascular device developers down the path to approval.

Learning Objectives

Following this webinar, attendees will understand how to avoid the pitfalls and challenges of conducting CV clinical trials.

• Understand critical trial design considerations, including comparator strategy, blinding, site and patient selection
• Learn how to create meaningful, measurable endpoints for effective evaluation
• Recognize how and when to utilize core lab services

Principal investigators and sites:

Because of subspecialist overlap in cardiovascular device treatment, sponsors may find themselves in competition for particular physicians to participate as principal investigators. Sponsors cannot assume that certification and expertise in one type of device will translate to a different technology. When selecting a site, consider including locations with less extensive clinical research portfolios to increase the speed of patient recruitment.

Patient selection:

Many sponsors seek to enroll patients with long-standing heart conditions. However, this practice adds levels of complexity that threaten timelines as it impacts patient identification, informed consent and treatment decisions. It is important to model different trial populations to evaluate the potential efficacy and safety of the device.

Complexity in data collection:

Analyses and collection of data in cardiovascular trials requires a carefully defined process during protocol design. Sponsors and their partners need to agree on the markers, measures and methods that will precisely define the trial endpoints to assure those assessments are uniform across each trial site. Consider how other researchers are defining the measurements, along with the use of historic or predicate device data for baseline comparisons.

Lab partnership:

In addition to examining a device against a standard of care, some trial designs also may involve sham treatments or no interventions, as it is not common for device trials to be double- blinded. Therefore, the evaluation of study data by a single, blinded core laboratory or cardiac catheterization laboratory is essential.

Speakers

Eric Distad, Director of Project Management, Medical Device & Diagnostics Division, Novella Clinical

Eric Distad has more than 18 years’ experience in all facets of clinical research including 16 years in medical device clinical research, ranging from one of the top three medical device companies to start-up companies. He has been responsible for the development and management of more than 20 IDE studies including protocol development through final report/submission to regulatory authorities. His experience includes primarily Class III devices with indications in neurology, cardiac, vascular and spine disorders. Geographically, Mr. Distad has significant experience managing trials in the United States, Canada, Europe and Hong Kong/China.

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Ori Ben-Yehuda, MD, FACC, Executive Director, Cardiovascular Research Foundation (CRF) Clinical Trials Center

Ori Ben-Yehuda is a distinguished clinical cardiologist and author of numerous scientific publications in top tier medical journals. Most recently, Dr. Ben-Yehuda was Vice President, Cardiovascular Clinical Research at Gilead Sciences. Prior to that, he was Professor of Clinical Medicine at the University of California, San Diego (UCSD) and the Director of the Coronary Care Unit at UCSD Medical Center. Dr. Ben-Yehuda also served as the Deputy Editor of the Journal of the American College of Cardiology until 2010 and is presently an Associate Editor on the Journal. At CRF Dr. Ben-Yehuda leads a team of 60 clinical scientists, statisticians, programmers and project managers, providing ARO services including angiographic core labs, trial design, data management and statistics.

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